Medical implant delivery system and related methods

ABSTRACT

An implant delivery device for introducing and positioning implants within patients may include a sheath member having a distal end, a proximal end, and a central longitudinal axis, the sheath member defining a lumen along the central longitudinal axis. The implant delivery device may additionally include an implant delivery shaft having a distal end and a proximal end, the implant delivery shaft disposed at least partially within the sheath member and an implant spreader assembly disposed at the distal end of the implant delivery shaft. In some embodiments, the implant delivery device may further include a cap disposed at the distal end of the sheath member, the cap obstructing at least a portion of an opening into the lumen of the sheath member.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/147,106, filed May 5, 2016, which claims the benefit of priorityunder 35 U.S.C. § 119 to U.S. Provisional Application Ser. No.62/157,674, filed May 6, 2015, the entirety of which are incorporatedherein by reference.

TECHNICAL FIELD

The present disclosure pertains generally, but not by way of limitation,to medical devices, and methods for manufacturing medical devices. Moreparticularly, the present disclosure pertains to devices for introducingand positioning implants within patients, and methods for manufacturingand using such devices.

BACKGROUND

With its complexity, range of motion and extensive use, a common softtissue injury is damage to the rotator cuff or rotator cuff tendons.Damage to the rotator cuff is a potentially serious medical conditionthat may occur during hyperextension, from an acute traumatic tear orfrom overuse of the joint. Adequate procedures do not exist forrepairing a partial thickness tear of less than 50% in the supraspinatustendon. Current procedures attempt to alleviate impingement or make roomfor movement of the tendon to prevent further damage and relievediscomfort but do not repair or strengthen the tendon. Use of the stilldamaged tendon can lead to further damage or injury. There is an ongoingneed to deliver and adequately position medical implants during anarthroscopic procedure in order to treat injuries to the rotator cuff,rotator cuff tendons, or other soft tissue or tendon injuries throughouta body.

BRIEF SUMMARY

The disclosure describes various medical devices and methods for usingmedical devices to assist in delivering and positioning implants withina body. In a first example, an implant delivery system may comprise asheath member having a distal end, a proximal end, and a centrallongitudinal axis, the sheath member defining a lumen along the centrallongitudinal axis and an implant delivery shaft having a distal end anda proximal end, where the implant delivery shaft disposed at leastpartially within the sheath member. In some examples, the implantdelivery system may additionally include an implant spreader assemblydisposed at the distal end of the implant delivery shaft and a capdisposed at the distal end of the sheath member, where the cap obstructsat least a portion of an opening into the lumen of the sheath member.

Alternatively, or additionally, in the above example, the cap maycomprise a plurality of petals.

Alternatively, or additionally, in any of the above examples, the capmay comprise an even number of petals.

Alternatively, or additionally, in any of the above examples, each ofthe plurality of petals may be disposed opposite another of theplurality of petals.

Alternatively, or additionally, in any of the above examples, the capmay comprise six petals.

Alternatively, or additionally, in any of the above examples, the petalsare configured to collapse together when inserted into tissue.

Alternatively, or additionally, in any of the above examples, whencollapsed together, the petals form a plug and prevent tissue fromentering the lumen of the sheath member as the implant delivery systemis advanced into the tissue.

Alternatively, or additionally, in any of the above examples, each ofthe petals may comprise a recessed portion.

Alternatively, or additionally, in any of the above examples, the petalsmay curve inward toward the central longitudinal axis.

Alternatively, or additionally, in any of the above examples, at least aportion of the opening into the lumen may be unobstructed by the cap.

Alternatively, or additionally, in any of the above examples, at least aportion of the cap may be disposed at least partially within the lumenof the sheath member.

Alternatively, or additionally, in any of the above examples, the capmay be tethered to the sheath member.

Alternatively, or additionally, in any of the above examples, the distalend of the sheath member may be angled.

Alternatively, or additionally, in any of the above examples, the capmay be hingedly connected to the sheath member.

Alternatively, or additionally, in any of the above examples, theimplant delivery system may further comprise a sealing member disposedon at least a portion of the implant delivery shaft that is disposedwithin the sheath member.

In another example, an implant delivery system for delivering an implantto a target site may comprise a sheath member having a distal end, aproximal end, and a central longitudinal axis, the sheath memberdefining a lumen along the central longitudinal axis, and an implantdelivery shaft having a distal end and a proximal end, the implantdelivery shaft disposed at least partially within the sheath member,wherein the implant delivery shaft comprises a first section with afirst diameter, a second section with a second diameter, and a thirdsection with a third diameter, wherein each of the first diameter,second diameter, and third diameter have different values. In someexamples, the implant delivery system may additionally include animplant spreader assembly disposed at the distal end of the implantdelivery shaft.

Alternatively, or additionally, in the above example, the implantdelivery system may further comprise a proximal movement lock engagedwith the sheath member and disposed around the implant delivery shaftproximal of the third section of the implant delivery shaft, theproximal movement lock preventing the third section of the implantdelivery shaft from being advanced proximal of the proximal movementlock.

Alternatively, or additionally, in any of the above examples, theimplant delivery may further comprise a distal movement lock, the distalmovement lock having a closed position and an open position, wherein inthe closed position the distal movement lock is engaged with the implantdelivery shaft and prevents the implant delivery shaft from beingadvanced distally, and wherein in the open position, the distal movementlock is disengaged from the implant delivery shaft and allows theimplant delivery shaft to be advanced distally.

Alternatively, or additionally, in any of the above examples, whendistal movement lock is engaged with the implant delivery shaft, thedistal movement lock may be engaged along the second section of theimplant delivery shaft.

In still another example, a method for delivering a sheet-like implantto a target site may comprise positioning an implant delivery systemproximate an incision in a patient, wherein the implant delivery systemcomprises: a sheath member having a distal end, a proximal end, and acentral longitudinal axis, the sheath member defining a lumen along thecentral longitudinal axis, an implant delivery shaft having a distal endand a proximal end, the implant delivery shaft disposed at leastpartially within the sheath member, an implant spreader assemblydisposed at the distal end of the implant delivery shaft, a sheet-likeimplant disposed on the implant spreader assembly in a foldedconfiguration, and a cap disposed at the distal end of the sheathmember, the cap comprising a plurality of petals and obstructing atleast a portion of an opening into the lumen of the sheath member. Insome examples, the method may further comprise inserting the implantdelivery system into the incision and advancing the implant deliverysystem to the target implant site. Finally, in some examples, the methodmay comprise advancing the implant delivery shaft distally, wherein thedistal movement of the implant delivery shaft causes at least some ofthe plurality of petals to expand outward away from the centrallongitudinal axis, the distal movement further uncovering the implantspreader assembly and the sheet-like implant from within the sheathmember, and wherein, when uncovered, the implant spreader assemblyunfolds the sheet-like implant from the folded configuration to anunfolded configuration.

Alternatively, or additionally, in the above example, the method mayfurther comprise securing the sheet-like implant to the target site.

Alternatively, or additionally, in any of the above examples, each ofthe plurality of petals may be disposed opposite another of theplurality of petals.

The above summary of some examples and embodiments is not intended todescribe each disclosed embodiment or every implementation of thepresent disclosure. The Brief Description of the Drawings, and DetailedDescription, which follow, more particularly exemplify theseembodiments, but are also intended as exemplary and not limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is perspective view of an exemplary implant delivery system,according to an example of the present disclosure;

FIG. 2 is perspective view of an exemplary sheath member of the implantdelivery system of FIG. 1, according to an example of the presentdisclosure;

FIG. 3 is an exploded view of an exemplary implant delivery shaft andimplant spreader assembly of the implant delivery system of FIG. 1,according to an example of the present disclosure;

FIG. 4 is a perspective view of an exemplary implant delivery shaft andimplant spreader assembly of the implant delivery system of FIG. 1,according to an example of the present disclosure;

FIG. 5 is a perspective view of an exemplary cap of the implant deliverysystem of FIG. 1, according to an example of the present disclosure;

FIG. 6 is a front plan view of the cap of FIG. 5;

FIG. 7 is an exploded view of the implant delivery shaft of FIG. 4 andan exemplary distal movement lock, according to an example of thepresent disclosure;

FIG. 8 is an exploded view of the implant delivery shaft of FIG. 4 andan exemplary proximal movement lock, according to an example of thepresent disclosure;

FIGS. 9 and 10 are perspective views of an alternative exemplary cap,according to an example of the present disclosure;

FIGS. 11 and 12 are perspective views of another alternative exemplarycap, according to an example of the present disclosure;

FIG. 13 is a stylized anterior view of a patient with a shoulder beingshown in cross-section, according to an example of the presentdisclosure;

FIG. 14 is a stylized view of a shoulder depicting a head of the humerusshown mating with the glenoid fossa of the scapula at a glenohumeraljoint and an implant affixed to a tendon, according to an according toan example of the present disclosure;

FIG. 15A is a stylized perspective view showing a portion of the body ofa human patient divided into quadrants by planes, according to anexample of the present disclosure;

FIG. 15B is a stylized perspective view illustrating an exemplaryprocedure for arthroscopic treatment of a shoulder of a patient,according to an example of the present disclosure;

FIG. 16A is a partial view of a shoulder including an exemplary implantdelivery device, according to an example of the present disclosure; and

FIG. 16B is a partial view of a shoulder including a deployed sheet-likeimplant, according to an example of the present disclosure.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the disclosure.

DETAILED DESCRIPTION

The following description should be read with reference to the drawings,which are not necessarily to scale, wherein like reference numeralsindicate like elements throughout the several views. The detaileddescription and drawings are intended to illustrate but not limit theclaimed invention. Those skilled in the art will recognize that thevarious elements described and/or shown may be arranged in variouscombinations and configurations without departing from the scope of thedisclosure. The detailed description and drawings illustrate exampleembodiments of the claimed invention.

Definitions of certain terms are provided below and shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same or substantiallythe same function or result). In many instances, the terms “about” mayinclude numbers that are rounded to the nearest significant figure.Other uses of the term “about” (i.e., in a context other than numericvalues) may be assumed to have their ordinary and customarydefinition(s), as understood from and consistent with the context of thespecification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

As used in this specification and the appended claims, the singularforms “a,” “an,” and “the” include or otherwise refer to singular aswell as plural referents, unless the content clearly dictates otherwise.As used in this specification and the appended claims, the term “or” isgenerally employed to include “and/or,” unless the content clearlydictates otherwise.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment(s) described may include a particular feature, structure, orcharacteristic, but every embodiment may not necessarily include theparticular feature, structure, or characteristic. Moreover, such phrasesare not necessarily referring to the same embodiment. Further, when aparticular feature, structure, or characteristic is described inconnection with an embodiment, it would be within the knowledge of oneskilled in the art to affect such feature, structure, or characteristicin connection with other embodiments, whether or not explicitlydescribed, unless clearly stated to the contrary. That is, the variousindividual elements described below, even if not explicitly shown in aparticular combination, are nevertheless contemplated as beingcombinable or able to be arranged with each other to form otheradditional embodiments or to complement and/or enrich the describedembodiment(s), as would be understood by one of ordinary skill in theart.

FIG. 1 provides a perspective view of implant delivery system 100. In atleast some embodiments, implant delivery system 100 comprises sheathmember 101, implant delivery shaft 103, cap 105, distal movement lock170, and proximal movement lock 180. Implant delivery system 100 mayadditionally comprise implant spreader assembly 107 residing withinsheath member 101 and connected to implant delivery shaft 103, asdepicted in other figures.

Generally, to deliver an implant, such as a sheet-like implant, to atarget implant site of a patient, a physician may create an incision inthe patient opening into the target implant site. The physician may theninsert implant delivery system 100 into the incision and position theproximal end of implant delivery system 100, including cap 105, at thetarget implant site. The physician may then manipulate implant deliveryshaft 103 to force implant spreader assembly 107, including a sheet-likeimplant, out of sheath member 101, through cap 105, and adjacent to thetarget implant site. The physician may then attach the sheet-likeimplant to the target implant site and remove implant delivery system100 from the patient.

Turning more specifically to sheath member 101, as depicted in FIG. 2,in at least some embodiments, sheath member 101 may include ribs 111,handles 113, holes 115, and flange 119. However, in other embodiments,sheath member 101 may not include one or more of these members orfeatures. For instance, in some embodiments, sheath member 101 may notinclude ribs 111 or holes 115. In some instances sheath member 101 maybe monolithically formed to include ribs 111, handles 113, holes 115,and flange 119. However, in other instances sheath member 101 may beformed of multiple components. Additionally, as can be seen, sheathmember 101 extends along central longitudinal axis 112 and defines lumen117. Sheath member 101 additionally includes openings at both distal end116 and proximal end 114 of sheath member 101.

Ribs 111 may generally extend away from sheath member 101 in a radiallyoutward direction, or in other embodiments, proximally toward proximalend 114. When implant delivery system 100 is inserted into an incision,ribs 111 may provide a retention force holding implant delivery system100 within the incision. This feature of ribs 111 may be particularlyuseful in situations where the target implant site is inflated with oneor more injected liquids, which may provide pressure against implantdelivery system 100 working to force implant delivery system 100 out ofthe incision.

Handles 113 are depicted as being attached proximate proximal end 114 ofsheath member 101 and are generally circular in shape. However, in otherembodiments, handles 113 may be attached to sheath member 101 at otherlocations and take on other shapes that provide a surface for a user tograsp. For example, handles 113 may be semi- or half-circular in shape,instead of fully circular as depicted in FIG. 2, or may be shaped toconform to one or more fingers for comfortable use when grasped by auser. In other embodiments, handles 113 may simply be tabs that extendgenerally outward away from sheath member 101, which provide a surfacefor grasping with one or more fingers.

Holes 115 are depicted disposed proximate distal end 116 of sheathmember 101. Holes 115 may have a sufficient diameter to allow for fluidto pass into lumen 117 of sheath member 101. For instance, in someembodiments, a sheet-like implant may be loaded onto implant spreaderassembly 107, located within lumen 117 of sheath member 101, in a drycondition. Before using implant delivery system 100 to deploy thesheet-like implant to the target site, a user may submerge the distalend of sheath member 101 in a hydrating agent, which may pass into theinterior of sheath member 101 through holes 115 and hydrate thesheet-like implant. In other instances, the target implant site may beinflated with one or more liquid agents in order to provide a greaterworking volume for maneuvering implant delivery system 100 at the targetimplant site. In such instances, the one or more liquid agents used toinflate the target implant site may act as hydrating agents for thesheet-like implant, for example by traversing holes 115 and contactingthe sheet-like implant retained on implant spreader assembly 107.

FIG. 3 depicts implant delivery shaft 103 and implant spreader assembly107 of implant delivery system 100 with sheath member 101 removed.Implant delivery shaft 103 has proximal end 121 and distal end 122.Additionally, implant delivery shaft 103 may be divided into differentsections that have different diameters. For instance, implant deliveryshaft 103 may have first section 125, second section 126, third section127, and fourth section 128. First section 125 may have a firstdiameter, second section 126 may have a second diameter, third section127 may have a third diameter, and fourth section 128 may have a fourthdiameter. In at least some embodiments, all of the diameters may bedifferent. For example, the second diameter may be less than the firstdiameter, and the third diameter may be greater than the first diameter.However, in some other embodiments, the fourth diameter may be the sameas the first diameter. Although, in still other embodiments, the fourthdiameter may be greater than, or less than, the first diameter.

In still other embodiments, implant delivery shaft 103 may have fewerthan four sections. For instance, in some embodiments, implant deliveryshaft 103 may have a first section, a second section, and a thirdsection. In some of these embodiments, each section may have differingdiameters, and in other embodiments, the first section and the thirdsection, which may be separated by the second section, have the samediameter. In these embodiments, the second section may then have asmaller diameter. In other embodiments, however, the third section mayhave a larger or smaller diameter than the first section. In general,these are just example configurations of implant delivery shaft 103. Thepresent disclosure contemplates variations of implant delivery shafthaving any number of sections with any number of different diameters andwherein each section has a different or similar diameter than any othersection in all variations.

As will be described in more detail below, the different diameters ofimplant delivery shaft 103 may, in conjunction with other members ofimplant delivery system 100, operate to prevent movement of implantdelivery shaft 103 relative to sheath member 101.

Generally, the third diameter of third section 127 is less than thediameter of lumen 117, thereby allowing implant delivery shaft 103 tofit within sheath member 101. In at least some embodiments, thirdsection 127 may additionally include a sealing member (not shown)disposed on third section 127. For instance, the sealing member may be arubber or silicone o-ring like member disposed around third section 127.As described, in some instances one or more liquid agents may be pumpedinto the target implant site under pressure in order to inflate thetarget implant site. In embodiments where the sealing member isincluded, the sealing member may operate to prevent the one or moreliquid agents from traversing distally, or proximally, of the sealingmember. For instance, the sealing member may prevent the one or moreliquid agents from traversing from the target implant site, up throughlumen 117 of sheath member 101, and out the proximal end of implantdelivery system 100 (and out of the patient). In other embodiments, thesealing member may comprise a coating that is applied to the surface ofthird section 127 in order to create a seal between the inside of sheathmember 101 and third section 127. In other embodiments, the sealingmember may be disposed on one of the other sections of implant deliveryshaft 103. Implant delivery shaft 103 may include multiple sealingmembers located on different sections of implant delivery shaft 103.

Implant delivery shaft 103 may additionally comprise pushing member 123attached to proximal end 121. Although shown as a generally circularcomponent, in other embodiments, pushing member 123 may have any of anumber of other suitable shapes. In general, pushing member 123 may havea diameter that is greater than that of any of sections 125, 126, 127,or 128 of implant delivery shaft 103. The greater diameter of pushingmember 123 may provide a greater surface area for a user to applypushing forces to implant delivery shaft 103. Additionally, inembodiments where the diameter of pushing member 123 is greater than theopening at proximal end 114 of sheath member 101, a user may only beable to advance implant delivery shaft 103 in the distal direction untilpushing member 123 contacts flange 119 of sheath member 101.

In some embodiments, implant delivery shaft 103 may additionally includereceiving member 124 attached to distal end 122 of implant deliveryshaft 103. Although shown as having a diameter larger than fourthsection 128 of implant delivery shaft 103, in other embodiments,receiving member 124 may have a smaller diameter, or a substantiallysimilar diameter, to fourth section 128. Receiving member 124 may definea cavity for receiving implant spreader assembly 107. For instance,receiving member 124 may define an opening at the distal end ofreceiving member 124. In at least some embodiments, receiving member 124may additionally include windows 129.

FIG. 3 additionally depicts implant spreader assembly 107, includingretention members 131. Retention member 131 may include a flat portion133 and a raised portion 135. Additionally, in some embodiments, eachretention member 131 may taper as each retention member 131 extendsproximally. This taper may make inserting implant spreader assembly 107into receiving member 124 easier.

When implant spreader assembly 107 is received within receiving member124, retention members 131 of implant spreader assembly 107 may bedisposed at least partially within windows 129 to retain implantspreader assembly 107 on implant delivery shaft 103, as shown in FIG. 4.More specifically, at least a portion of raised portions 135 may bedisposed at least partially within windows 129, as shown in FIG. 4.

FIG. 4 additionally depicts other features of implant spreader assembly107. For example, implant spreader assembly 107 may comprise first andsecond halves 142, 143. First half 142 may comprise body 144 and firstpost 145 extending generally distally away from body 144. Second half143 may comprise body 146 and second post 147. In a similar manner tofirst post 145, second post 147 may also extend generally distally awayfrom body 146. However, in contrast to first post 145, second post 147may curve so that, when first half 142 and second half 143 are joined,second post 147 curves toward first post 145. When first half 142 andsecond half 143 are joined, first post 145 and second post 147 maydefine a slot with a narrow opening for receiving a sheet-like implant.For example, when retained on implant spreader assembly 107, asheet-like implant may extend between first post 145 and second post147. In other embodiments, implant spreader assembly 107 may comprise asingle, unitary member, including first post 145 and second post 147.

Implant spreader assembly 107 may additionally include implant spreaders151. As shown, each implant spreader 151 comprises an arm 152 ending inhead 153. However, in other embodiments, implant spreaders 151 may havedifferent shapes. For example, each implant spreader 151 may comprisemultiple arms 152 and/end in multiple heads 153. Additionally, althoughFIG. 4 only depicts four implant spreaders 151, in other embodiments,implant spreader assembly 107 may include more or fewer implantspreaders 151.

In some embodiments, implant spreaders 151 may have a plurality ofconfigurations. For instance, implant spreaders 151 may have a compactconfiguration, as shown in FIG. 4, where each arm 152 curves toward anopposing arm 152. Implant spreaders 151 may be disposed in this compactconfiguration, for example, when implant spreader assembly 107 isretained within lumen 117 of sheath member 101. When implant spreaders151 are in an expanded configuration, each arm 152 may not curve and mayinstead extend in the same plane outward away from posts 145, 147.Implant spreaders 151 may be disposed in the expanded configuration, forexample, when implant spreader assembly 107 is disposed outside lumen117 of sheath member 101. Accordingly, when a sheet-like implant isretained on implant spreader assembly 107, the sheet-like implant mayassume a curled or rolled configuration around implant spreaders 151,and may be constrained from unrolling when disposed within lumen 117 ofsheath member 101 along with implant spreader assembly 107. However,once implant spreader assembly 107 is moved outside of lumen 117 ofsheath member 101, implant spreaders 151 may assume their expandedconfiguration, thereby expanding or unfolding the sheet-like implantinto a generally planar configuration.

Accordingly, in at least some embodiments, implant spreaders 151 may bemade of a material that may deform elastically into one or more shapesin order to fit within the confines of sheath member 101. Some suitableexample materials include metals and metal alloys including stainlesssteel, such as 304V, 304L, and 316LV stainless steel; mild steel;nickel-titanium alloy such as linear-elastic and/or super-elasticnitinol; other nickel alloys such as nickel-chromium-molybdenum alloys(e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY®C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys,and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL®400, NICKELVAC® 400, NICORROS® 400, and the like),nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such asMP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 suchas HASTELLOY® ALLOY B2®), other nickel-chromium alloys, othernickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-ironalloys, other nickel-copper alloys, other nickel-tungsten or tungstenalloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenumalloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like);platinum enriched stainless steel; titanium; combinations thereof; andthe like; or any other suitable material.

As alluded to above, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear that the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also can be distinguished based on its composition),which may accept only about 0.2 to 0.44 percent strain beforeplastically deforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In atleast some embodiments, the mechanical bending properties of the linearelastic and/or non-super-elastic nickel-titanium alloy at ambient orroom temperature are substantially the same as the mechanical propertiesat body temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some cases, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Some examples of nickel titanium alloys aredisclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which areincorporated herein by reference. Other suitable materials may includeULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available fromToyota). In some other embodiments, a superelastic alloy, for example asuperelastic nitinol can be used to achieve desired properties.

In other embodiments, implant spreaders 151 may be constructed of one ormore of the above described materials configured as an inlay. Forinstance implant spreaders 151 may comprise a metal structure encased inone or more other materials, such as a plastic or silicone material. Theplastic or silicone material may be molded either completely or partlyover the metal structure. Such hybrid-material structures may reduce themanufacturing cost of producing implant spreaders 151 or provide implantspreaders 151 with physical properties unable to be achieved by usingonly metal.

FIG. 5 is a perspective view of cap 105. In some embodiments, cap 105may make it easier for a user to insert implant delivery system 100 intothe patient, for example by allowing use of implant delivery system 100without an obturator. For instance, cap 105 may help to keep tissue fromentering lumen 117 of sheath member 101 as implant delivery system 100is inserted into tissue through an incision in the patient. In someembodiments, cap 105 formed separately from sheath member 101 and may beattached to distal end 116 of sheath member 101 using one or moreadhesives, by laser welding, with a friction fit, or any other suitablemeans for attachment. Forming cap 105 separate from sheath member 101may allow for attachment of implant spreader assembly 107 to implantdelivery shaft 103 after implant delivery shaft 103 has been insertedinto lumen 117 of sheath member 101. However, in other embodiments, cap105 may be formed integrally with sheath member 101 and implant spreaderassembly 107 may be attached to implant delivery shaft 103 beforeimplant delivery shaft 103 is loaded into sheath member 101.

In general, cap 105 may comprise a plurality of petals 161. Each petal161 may curve inward toward central longitudinal axis 112 (as depictedin FIG. 2) and taper as each petal 161 extends distally, so as to createnarrow opening 167. In at least some embodiments, cap 105 comprises aneven number of petals 161. More specifically, in at least someembodiments, cap 105 comprises four, six, eight, ten, or any othersuitable number of petals. However, in other embodiments, cap 105 maycomprise an odd number of petals 161.

In examples where cap 105 comprises an even number of petals 161, asimplant delivery system 100 is being inserted into an incision, oppositepetals 161 may collapse against each other when being advanced throughthe incision and into tissue due to tissue pressing on cap 105, therebysubstantially closing narrow opening 167. This may help prevent tissuefrom entering lumen 117 of sheath member 101. For instance, each petal161 may have a thickness extending from an outer surface to an innersurface, forming face 166. The petal thickness may vary in differentembodiments between about 0.05 inches (1.27 mm) and about 0.15 inches(3.81 mm). As a force is applied to the outer surface of petals 161 andpetals 161 collapse together such that faces 166 of one petal 161converge with adjacent faces 166 of adjacent petals 161, faces 166 maybecome pressed together. In this manner, each of petals 161 may supporteach other when a force is applied to the outer surface of petals 161.The thickness and configuration of petals 161 may help to prevent petals161 from buckling inward at points between tips 163 and bases 165 whenforces are applied to the outside surface of petals 161. With faces 166pressed together (e.g. abutting one another), petals 161 may form asolid plug which prevents tissue from entering lumen 117 of sheathmember 101 as implant delivery system 100 is advanced through tissue.

Additionally, when faces 166 are pressed together under a force actingon the outside surface of petals 161, petals 161 may translate suchforces into a force acting in a substantially axial direction at bases165, for instance along central longitudinal axis 112. In at least someembodiments, bases 165 may be relatively flexible in directionsperpendicular to the central longitudinal axis 112, but may beinflexible in directions along central longitudinal axis 112. Forexample, petals 161 may taper in thickness from tips 163 to bases 165.This configuration may create a hinge-like connection between petals 161and the rest of cap 105.

As discussed, when a force is applied to the outer surface of petals161, petals 161 are configured to collapse together. However, when aforce is applied to an inner surface of petals 161 (e.g., from aninterior of the cap 105, the force pushes petals 161 in an outwarddirection away from each other. If the force is large enough, petals 161will bend at bases 165 and diverge from one another, exposing lumen 117of sheath member 101. For example, when implant delivery system 100 ispositioned at an implant location, a user may advance implant deliveryshaft 103 distally relative to sheath member 101. As the user advancesimplant spreader assembly 107 distally, implant spreader assembly 107may push against the inside surface of petals 161. This pushing forcemay cause each petal 161 to bend outward at or near base 165, therebycausing tips 163 to expand outward way from central longitudinal axis112 and causing narrow opening 167 to expand to allow implant spreaderassembly 107 to be advanced distally beyond petals 161.

In some additional embodiments, as depicted in FIG. 5, each petal 161may have a recessed portion 169. Recessed portions 169 may allow petals161 to be formed from less overall material and/or may help in reducingthe thickness of petals 161 at tips 163 and at bases 165, therebyincreasing the flexibility of petals 161 at bases 165 relative to tips163. In still additional embodiments, faces 166 may include a series ofinterlocking protrusions and grooves. The protrusions on a first petal161 may be aligned with grooves on a second, adjacent petal 161 suchthat when faces 166 are compressed together, the protrusions of thefirst petal 161 extend into the grooves on the second petal 161. Theseseries of protrusions and grooves may help to prevent petals 161 fromslipping past one another or otherwise deviating from a tight,compressed configuration when a force is applied to the outer surface ofpetals 161.

FIG. 6 is a front-plan view of cap 105, more closely detailing narrowopening 167. In different embodiments, the gap between opposing tips 163of petals 161 may be between about 0.010 inches (0.254 mm) and about0.025 inches (0.635 mm). Additionally, this gap between petals 161 attips 163 may narrow toward bases 165 of petals 161. For instance, thegap may narrow to between about 0.006 inches (0.152 mm) and about 0.015inches (0.381 mm) at bases 165 of petals 161. Gaps of these sizes mayallow cap 105 to be manufactured using injection molding techniques thatwould be unavailable if petals 161 were formed with no gaps betweenpetals 161. In some instances, cap 105 may be molded as a solid piece,and then undergo a secondary operation to form gaps to define petals161, such as using a laser or razor, for example.

However, in other embodiments, cap 105 may not have narrow opening 167.Rather, cap 105 may have no opening. For instance, petals 161 may beformed so that petals 161 are pressed together to completely seal offlumen 117 of sheath member 101. In some of these embodiments, slits maybe formed between petals 161 to weaken a bond between petals 161 suchthat a force acting on petals 161 from inside sheath member 101, such asby implant spreader assembly 107, petals 161 may expand apart from oneanother exposing the lumen of sheath member 101. In other embodiments,cap 105 may include narrow opening 167, but a thin membrane-like member(not shown) may be placed over petals 161. The membrane-like member maybe made from one or more various plastic, silicone, rubber, or othersuitable materials. The membrane-like member may help prevent tissuefrom entering lumen 117 of sheath member 101 when implant deliverysystem 100 is inserted into a patient. However, the membrane-like membermay be fragile enough such that the membrane-like member breaks or tearswhen a user advances implant delivery shaft 103 distally, causing petals161 to bend outward expanding narrow opening 167.

FIG. 7 depicts distal movement lock 170 along with implant deliveryshaft 103. Distal movement lock 170, when engaged with implant deliveryshaft 103, may prevent implant delivery shaft 103 from being advanceddistally. For instance, distal movement lock 170 may comprise firsthandle 173, second handle 175, and opening 171. When distal movementlock 170 is engaged with implant delivery shaft 103, opening 171 may beengaged with second section 126. For instance, the diameter of opening171 may be slightly smaller than the second diameter of second section126 such that, when distal movement lock 170 is engaged with implantdelivery shaft 103, distal movement lock 170 grips second section 126.Additionally, the diameter of opening 171 in the unstressed state mayhave a diameter that is less than the first diameter of first section125. Accordingly, when engaged with implant delivery shaft 103, thesmaller diameter of opening 171 may prevent implant delivery shaft 103from being advanced distally.

Once a user has positioned implant delivery system 100 at the targetimplant site and is ready to deploy the sheet-like implant, the user maysqueeze together first handle 173 and second handle 175. This action maytransition distal movement lock 170 into a stressed state and may act toincrease the diameter of opening 171. In this stressed state, distalmovement lock 170 may be easily removed from around second section 126,thereby allowing the user to advance implant delivery shaft 103distally.

In some embodiments, distal movement lock 170 may additionally includeretention member 177. In some embodiments, retention member 177 maycomprise narrow portion 179 a and wide portion 179 b. In suchembodiments, retention member 177 may engage with another member ofimplant delivery system 100, and allow for rotational movement of distalmovement lock 170 relative to the other member of implant deliverysystem 100. In such embodiments, after the user has squeezed handles 173and 175 together, distal movement lock 170 may be rotated away fromimplant delivery shaft 103.

FIG. 8 depicts proximal movement lock 180. In some embodiments, proximalmovement lock 180 may be comprised of two sections, first section 184and second section 185. When connected together, first section 184 andsecond section 185 may form one or more openings. For instance, asdepicted in FIG. 8, first section 184 of proximal movement lock 180defines a number of openings, opening 182 a and opening 183. Secondsection 185 additionally defines slot 185. Although not explicitly shownin the perspective view in FIG. 8, in general, each of first section 184and second section 185 may define one portion of an opening or slotthat, when halves 184, 185 are put together, define an entire opening orslot.

For instance, when halves 184, 185 are put together, opening 182 a and182 b come together to form a single opening. The opening formed byopening 182 a and 182 b may have a diameter that is smaller than thethird diameter of third section 127. Accordingly, when implant deliverysystem 100 is fully assembled and proximal movement lock 180 is inplace, the opening formed by opening 182 a and 182 b only allows implantdelivery shaft 103 to be advanced proximally until third section 127contacts proximal movement lock 180.

In a similar manner, when halves 184, 185 are put together, halves 184,185 form slot 181. Slot 181 may be sized to fit around flange 119 ofsheath member 101. Accordingly, to attach proximal movement lock 180 tosheath member 101, halves 184, 185 may be connected together aroundflange 119 such that flange 119 resides within slot 181 to secureproximal movement lock 180 to sheath member 101.

In some embodiments, when halves 184, 185 are put together, halves 184,185 may additionally form opening 183. In these embodiments, opening 183may be sized to receive retention member 177 of distal movement lock170. For instance, narrow portion 179 a may fit through opening 183,while wide portion 179 b does not. Accordingly, if halves 184, 185 areconnected together with opening 183 around narrow portion 179 a, wideportion 179 b of retention member 177 may retain distal movement lock170 with proximal movement lock 180. In such a configuration, retentionmember 177 may still allow for rotational movement between distalmovement lock 170 and proximal movement lock 180.

Although shown in FIGS. 1, 7, and 8, and described in conjunction withimplant delivery system 100 above, some embodiments of implant deliverysystem 100 may not include distal movement lock 170 and/or proximalmovement lock 180. In other embodiments, implant delivery system 100 mayonly include a single locking member that prevents both proximal anddistal movement of implant delivery shaft 103 until the single lockingmember is opened.

FIGS. 9 and 10 depict an alternative embodiment of implant deliverysystem 100 including an alternate cap 205. For example, FIG. 9 depictssheath member 101 including cap 205. In these embodiments, cap 205 maybe a plug that fits at least partially within lumen 117 of sheath member101. For example, cap 205 may have a base portion 209 and a top portion208. Base portion 209 may be generally circular in diameter to conformto the inner wall of sheath member 101 when base portion 209 resideswithin lumen 117. Top portion 208 may have a taper as cap 205 extends inthe distal direction to aid with insertion into an incision. When baseportion 209 is inserted within sheath member 101, there may not be a gapbetween the walls of sheath member 101 defining lumen 117 and baseportion 209. In this manner, when cap 205 is inserted into sheath member101, cap 205 may prevent tissue from entering lumen 117 when implantdelivery system 100 is inserted into an incision in a patient.

Cap 205 may be additionally attached to sheath member 101 by tether 207.Tether 207 may be a piece of string, or wire, or any other suitableflexible material. Once implant delivery system 100 has been maneuveredto the target implant site, a user may advance implant delivery shaft103 distally. As this happens, implant spreader assembly 107 may pushagainst base portion 209 and may push cap 205 out of lumen 117, asdepicted in FIG. 10. Once cap 205 has been pushed out of lumen 117,implant spreader assembly 107 may be pushed, through additional distaladvancement of implant delivery shaft 103, distally past the opening atdistal end 116 of sheath member 101. Tether 207 may keep cap 205attached to sheath member 101 so that, as implant delivery system 100 isretracted from within the patient, cap 205 is also retracted.

FIGS. 11 and 12 depict another alternative embodiment of implantdelivery system 100 including an alternate cap 305. For example, FIG. 11depicts sheath member 101 including cap 305. In these embodiments, cap305 may comprise base portion 307 and flap or lid member 309. Lid member309 may be hollow and have a generally smooth, rounded outer surface andmay taper as cap 305 extends distally. Lid member 309 may also includehinged flap 308 that connected to the rest of lid member 309 by hinge306.

In some embodiments, base portion 307 may be generally flat and extendfrom distal end 116 of sheath member 101. When in a closed position, lidmember 309, including hinged flap 308, may fit together with baseportion 307 to seal off lumen 117 of sheath member 101. Accordingly,when implant delivery system 100 is inserted into a patient, lid member309 may prevent tissue from entering lumen 117. When implant deliverysystem 100 has been positioned at the target implant site, the user mayadvance implant delivery shaft 103 distally. This movement may causeimplant spreader assembly 107 push against the inside of lid member 309,and in particular the inside of hinged flap 308. This force againsthinged flap 308 may cause hinged flap 308 to rotate about hinge 306, forinstance in the direction of arrow R, exposing the lumen 117 of sheathmember 101, as shown in FIG. 12. Implant spreader assembly 107 may thenbe advanced distally beyond cap 305 to a target site and deployed.Implant spreader assembly 107 may then be retracted back into lumen 117of sheath 101 and implant delivery system may be withdrawn from thepatient.

In still other embodiments similar to FIGS. 11 and 12, instead of baseportion 307 being a part of cap 305, a portion of sheath member 101 mayextend distally beyond distal end 116 and act as base portion 307. Forinstance, cap 305 may only be comprised of lid member 309 which wouldfit together with the extension of sheath member 101 to seal off lumen117.

FIG. 13-16B illustrate an exemplary use or application of implantdelivery system 100. FIG. 13 is a stylized anterior view of patient 220.For purposes of illustration, shoulder 222 of patient 220 is shown incross-section in FIG. 13. Shoulder 222 includes humerus 214 and scapula212. In FIG. 13, head 224 of humerus 214 can be seen mating with aglenoid fossa of scapula 212 at a glenohumeral joint. The glenoid fossacomprises a shallow depression in scapula 212. The movement of humerus214 relative to scapula 212 is controlled by a number of musclesincluding: the deltoid, the supraspinatus, the infraspinatus, thesubscapularis, and the teres minor. For purposes of illustration, onlysupraspinatus 226 is shown in FIG. 13.

With reference to FIG. 13, distal tendon 228 of supraspinatus 226 meetshumerus 214 at an insertion point. Scapula 212 of shoulder 222 includesacromion 232. Subacromial bursa 234 is shown extending between acromion232 of scapula 212 and head 224 of humerus 214. Subacromial bursa 234 isshown overlaying supraspinatus 226 as well as supraspinatus tendon 228and a portion of humerus 214. Subacromial bursa 234 is one of thehundreds of bursae found the human body. Each bursa comprises a fluidfilled sac. The presence of these bursae in the body reduces frictionbetween bodily tissues.

Exemplary implant delivery system 100 described herein may be used toposition and deploy a sheet-like implant to various target tissuesthroughout the body. The shoulder depicted in FIG. 13 is one examplewhere the sheet-like implant may be affixed to one or more bonesassociated with an articulating joint, such as the glenohumeral joint.Additionally, the sheet-like implant may be affixed to one or moretendons to be treated. The tendons to be treated may be torn, partiallytorn, have internal micro-tears, be untorn, and/or be thinned due toage, injury or overuse. Implantation of the sheet-like implant at suchlocations may provide beneficial therapeutic effect on a patientexperiencing joint pain believed to be caused by partial thickness tearsand/or internal microtears. In some cases, applying the sheet-likeimplant early before a full tear or other injury develops may cause thetendon to thicken and/or at least partially repair itself, therebyavoiding more extensive joint damage, pain, and the need for moreextensive joint repair surgery.

FIG. 14 is a stylized anterior view of shoulder 222 including humerus214 and scapula 212. In FIG. 14, head 224 of humerus 214 is shown matingwith a glenoid fossa of scapula 212 at a glenohumeral joint.Supraspinatus 226 is also shown in FIG. 14. This muscle, along withothers, controls the movement of humerus 214 relative to scapula 212.Distal tendon 228 of supraspinatus 226 meets humerus 214 at insertionpoint 230.

As depicted in FIG. 14, distal tendon 228 includes first damaged portion236. A number of loose tendon fibers 240 in first damaged portion 236are visible in FIG. 14. First damaged portion 236 includes first tear242 extending partially through distal tendon 228. First tear 242 maytherefore be referred to as a partial thickness tear. With reference toFIG. 14, first tear 242 begins on the side of distal tendon 228 facingthe subacromial bursa (shown FIG. 13) and ends midway through distaltendon 228. Accordingly, first tear 242 may be referred to as a bursalside tear.

With reference to FIG. 14, distal tendon 228 includes second damagedportion 238 located near insertion point 230. As illustrated, seconddamaged portion 238 of distal tendon 228 has become frayed and a numberof loose tendon fibers 240 are visible. Second damaged portion 238 ofdistal tendon 228 includes second tear 244. Second tear 244 begins onthe side of distal tendon 228 facing the center of the humeral head 224.Accordingly, second damaged portion 238 may be referred to as anarticular side tear.

FIG. 14 illustrates sheet-like implant 250, which has been placed overthe bursal side of distal tendon 228. Sheet-like implant 250 is affixedto distal tendon 228 by a plurality of tendon staples 251. In someexamples, sheet-like implant 250 may comprise one or multiple of anumber of different materials without deviating from the spirit andscope of the present disclosure. In some examples, sheet-like implant250 may comprise a plurality of fibers. The fibers may be interlinkedwith one another. When this is the case, sheet-like implant 250 maycomprise a plurality of apertures comprising the interstitial spacesbetween fibers. Various processes may be used to interlink the fiberswith one another. Examples of processes that may be suitable in someapplications including weaving, knitting, and braiding. In someembodiments, sheet-like implant 250 may comprise a laminate includingmultiple layers of film with each layer of film defining a plurality ofmicro-machined or formed holes. Sheet-like implant 250 may also comprisea reconstituted collagen material having a porous structure.Additionally, sheet-like implant 250 may also comprise a plurality ofelectro-spun nanofiber filaments forming a composite sheet.Additionally, sheet-like implant 250 may comprise a synthetic spongematerial that defines a plurality of pores. Sheet-like implant 250 mayalso comprise a reticulated foam material. Reticulated foam materialsthat may be suitable in some applications are available from BiomerixCorporation of Fremont, Calif. which identifies these materials usingthe trademark BIOMERIX BIOMATERIAL™. Sheet-like implant 250 may becircular, oval, oblong, square, rectangular, or other shape configuredto suit the target anatomy.

Sheet-like implant 250 is affixed to humerus 214 by a plurality of bonestaples 252. Sheet-like implant 250 extends over insertion point 230,first tear 242 and second tear 244. In other cases, sheet-like implant250 may be placed on the bursal side of a tendon regardless of whetherthe tears being treated are on the bursal side, articular side or withinthe tendon. In some cases the exact location and nature of the tearsbeing treated may be unknown. Sheet-like implant 250 may be applied tothe bursal side of a tendon to treat shoulder pain that is most likelycaused by one or more partial thickness tears in the tendon.

FIG. 15A is a stylized perspective view showing a portion of body 282 ofhuman patient 220. Body 282 includes shoulder 222. In the exemplaryembodiment of FIG. 15A, a plurality of cannulas are positioned to accessa treatment site within shoulder 222. In some cases, shoulder 222 may beinflated by pumping a continuous flow of saline through shoulder 222 tocreate a cavity proximate the treatment site. The cannulas shown in FIG.15A include first cannula 280A, second cannula 280B and third cannula280C.

In FIG. 15A, a sagital plane SP and a frontal plane FP are shownintersecting body 282. Sagital plane SP and frontal plane FP intersectone another at a medial axis MA of body 282. With reference to FIG. 15A,sagital plane SP bisects body 282 into a right side 284 and a left side286. Also with reference to FIG. 15A, frontal plane FP divides body 282into an anterior portion 292 and a posterior portion 288. Sagital planeSP and a frontal plane FP are generally perpendicular to one another.These planes and portions are used to describe the procedures used inexemplary embodiments.

First cannula 280A is accessing a treatment site within shoulder 222using a lateral approach in which first cannula 280A pierces the outersurface of right side 284 of body 282. The term lateral approach couldalso be used to describe situations in which an instrument pierces theouter surface of left side 286 of body 282. Second cannula 280B isaccessing a treatment site within shoulder 222 using a posteriorapproach in which second cannula 280B pierces the outer surface ofposterior portion 288 of body 282. Third cannula 280C is accessing atreatment site within shoulder 222 using an anterior approach in whichthird cannula 280C pierces the outer surface of anterior portion 292 ofbody 282.

FIG. 15B is a stylized perspective view illustrating an exemplaryprocedure for treating a shoulder 222 of a patient 220 using implantdevice system 100. The procedure illustrated in FIG. 15B may include,for example, fixing tendon repair implants to one or more tendons ofshoulder 222. The tendons treated may be torn, partially torn, haveinternal micro-tears, be untorn, and/or be thinned due to age, injury oroveruse.

Shoulder 222 of FIG. 15B has been inflated to create a cavity therein. Afluid supply 252 is pumping a continuous flow of saline into the cavity.This flow of saline exits the cavity via a fluid drain 254. A camera 256provides images from inside the cavity. The images provided by camera256 may be viewed on a display 258. Camera 256 may be used to visuallyinspect the tendons of shoulder 222 for damage. In some cases,sheet-like implant 250 may be affixed to a bursal surface of the tendonregardless of whether there are visible signs of tendon damage.

Implant delivery system 100 may, for example, be inserted into shoulder222 through first cannula 280A. In certain embodiments, first cannula280A can access a treatment site within shoulder 222 using a lateralapproach in which first cannula 280A pierces the outer surface of aright side of the patient's body. In some cases a physician may choosenot to use a cannula in conjunction with implant delivery system 100.When that is the case, the implant delivery system 100 may be advancedthrough tissue.

Once implant delivery system 100 has been positioned within shoulder 222at the target implant site, sheet-like implant 250 may be deployed fromimplant delivery system 100. For instance, the physician may disengagedistal movement lock 180 from implant delivery system 100 and advanceimplant delivery shaft 103 distally until implant spreader assembly 107is uncovered from sheath member 101 and cap 105. Once implant spreaderassembly 107 is uncovered, implant spreaders 151 may expand or unfoldsheet-like implant within should 222.

Sheet-like implant 250 may then be affixed to the tendon while it isheld against the tendon by implant delivery system 100. Variousattachment elements may be used to fix the implant to the tendon.Examples of attachment elements that may be suitable in someapplications include sutures, tissue anchors, bone anchors, and staples.Various attachment elements may be used to fix sheet-like implant 250 tothe target implant site. Examples of attachment elements that may besuitable in some applications include sutures, tissue anchors, boneanchors, and staples. Details of exemplary tendon staples may be foundin commonly assigned co-pending applications: U.S. application Ser. No.12/684,774 filed Jan. 8, 2010; U.S. application Ser. No. 12/729,029filed Mar. 22, 2010; U.S. application Ser. No. 12/794,540 filed Jun. 4,2010; U.S. application Ser. No. 12/794,551 filed on Jun. 4, 2010; U.S.application Ser. No. 12/794,677 filed on Jun. 4, 2010; and U.S.Application No. 61/443,180 filed on Feb. 15, 2011, the disclosures ofwhich are incorporated herein by reference. Exemplary bone staples aredescribed in commonly assigned applications: U.S. Application No.61/577,626 filed Dec. 19, 2011; U.S. Application No. 61/577,632 filedDec. 19, 2011 and U.S. Application No. 61/577,635 filed Dec. 19, 2011,the disclosures of which are incorporated herein by reference. Exemplarystaples in many of the above applications may be used for anchoring inboth soft tissue and in bone.

In the exemplary embodiment of FIG. 15B, the shaft of a fixation tool210 is shown extending into shoulder 222. In one exemplary embodiment,fixation tool 210 is capable of affixing the implant to the tendon andbone with one or more staples while the implant may be held against thetendon by implant delivery system 100.

FIGS. 16A and 16B depict deployment of sheet-like implant 250 internallyto shoulder 222. In these illustrations, the supraspinatus tendon isused as an example only. Implant delivery system 100 may be used todeliver implants to other areas of the body.

A view of the bursal side of supraspinatus tendon 228 is illustrated inFIG. 16A. Although drawn with a clear visible line at the frontal marginof the supraspinatus tendon, due to other tissue and ligaments in thearea, this may generally not be visible to the surgeon through thearthroscope. Accordingly, in some examples, a physician may placemarkers (not shown) while viewing the biceps tendon from the articularside to delineate the front edge of where one would want to place theimplant.

Generally, implant delivery system 100 may be used without the aid of aguidewire. Accordingly, the physician may begin by simply inserting thedistal end of implant delivery system 100 into shoulder 222 through anincision or cannula and maneurvering the distal end to target implantsite 200, as shown in FIG. 16A.

Once the distal end of implant delivery system 100 is positioned attarget implant site 200, the physician may advance implant deliveryshaft 103 distally. If implant delivery system 100 includes an engageddistal movement lock, such as distal movement lock 170, the physicianmay need to first disengage the distal movement lock. As the physicianadvances implant delivery shaft 103 distally, implant spreader assembly107 attached to the distal end of implant delivery shaft 103 may beginto push on the inside of petals 161. This force may cause petals 161 toexpand outward, creating an opening to lumen 117 of sheath member 101,or widening an existing opening, such as narrow opening 167 describedwith respect to FIGS. 5 and 6. Once implant spreader assembly 107 hasbeen advanced distally beyond petals 161, implant spreader assembly 107may be completely uncovered by sheath member 101 and petals 161.

When sheet-like implant is loaded onto implant spreader assembly 107,sheet-like implant 250 may be wrapped, folded, or rolled around implantspreaders 151. Once implant spreaders 151 are uncovered, implantspreaders 151 may then expand from their compact configuration to theirexpanded configuration. Accordingly, this expanding motion may therebyimpart a force on sheet-like implant 250, causing sheet-like implant 250to expand or unfold into a generally planar configuration. FIG. 16Bdepicts where implant spreader assembly 107 has been advanced distallybeyond petals 161 and implant spreaders 151 have expanded sheet-likeimplant 250.

Once sheet-like implant 250 has been deployed at the target implantsite, sheet-like implant 250 can be attached in multiple locations tosupraspinatus tendon 228 using staples 251 or other fasteners, alsoshown in FIG. 16B. In at least some embodiments, spreaders 151 may beused to help hold sheet-like implant against supraspinatus tendon 228while staples 251 are deployed to secure sheet-like implant 250 tosupraspinatus tendon 228. Once the medial edge is attached, implantdelivery system 100 may then be removed from the target implant site.

It is to be understood that even though numerous characteristics ofvarious embodiments have been set forth in the foregoing description,together with details of the structure and function of variousembodiments, this detailed description is illustrative only, and changesmay be made in detail, especially in matters of structure andarrangements of parts illustrated by the various embodiments to the fullextent indicated by the broad general meaning of the terms in which theappended claims are expressed.

What is claimed:
 1. A method for delivering a sheet-like implant to atendon at a target site, the method comprising: positioning an implantdelivery system proximate an incision in a patient, the implant deliverysystem comprising: a sheath member having a distal end, a proximal end,and a central longitudinal axis, the sheath member defining a lumenalong the central longitudinal axis, an implant delivery shaft having adistal end and a proximal end, the implant delivery shaft disposed atleast partially within the sheath member, an implant spreader assemblydisposed at the distal end of the implant delivery shaft, a sheet-likeimplant disposed on the implant spreader assembly in a foldedconfiguration within the lumen of the sheath member, and a cap disposedat the distal end of the sheath member, the cap comprising a pluralityof petals and obstructing at least a portion of an opening into thelumen of the sheath member, wherein each petal of the plurality ofpetals includes a recessed portion on an outer surface thereof;inserting the implant delivery system into the incision; advancing theimplant delivery system to the tendon; and deploying the sheet-likeimplant from the lumen of the sheath member by withdrawing the sheathmember relative to the implant delivery shaft, wherein the movement ofthe sheet-like implant past the plurality of petal causes at least someof the plurality of petals to expand outward away from the centrallongitudinal axis, and wherein, deploying the sheet-like implantincludes unfolding the sheet-like implant with the implant spreader fromthe folded configuration to an unfolded configuration overlaying thetendon.
 2. The method of claim 1, further comprising securing thesheet-like implant to the tendon.
 3. The method of claim 1, wherein eachof the plurality of petals is disposed opposite another of the pluralityof petals.
 4. The method of claim 1, wherein, when collapsed together,the petals form a plug and prevent tissue from entering the lumen of thesheath member as the implant delivery system is inserted into theincision.
 5. The method of claim 4, wherein the plurality of petals areconfigured to collapse together when inserted into the incision.
 6. Themethod of claim 1, wherein each of the plurality of petals curve inwardtoward the central longitudinal axis.
 7. The method of claim 1, whereinthe implant delivery shaft comprises a first section with a firstdiameter, a second section with a second diameter, and a third sectionwith a third diameter, the second section located longitudinally betweenthe first section and the third section, wherein the second diameter isless than both the first diameter and the third diameter.
 8. The methodof claim 7, further comprising removing a distal movement lock fromaround the implant delivery shaft proximal of the third section of theimplant delivery shaft prior to deploying the sheet-like implant fromthe lumen of the sheath member.
 9. The method of claim 1, wherein theimplant spreader assembly includes four separate arms, wherein theimplant spreader assembly is expandable from a compact configurationwhen disposed within the lumen of the sheath member to an expandedconfiguration when advanced out of the lumen of the sheath member. 10.The method of claim 9, wherein the implant spreader assembly includes afirst post and a second post each extending longitudinally from thedistal end of the implant delivery shaft, wherein the sheet-like implantis positioned between the first and second posts.
 11. The method ofclaim 10, wherein the four arms extend outward from the first and secondposts.
 12. The method of claim 11, wherein first and second arms of thefour arms extend in opposite sides of the first and second posts at afirst location, and third and fourth arms of the four arms are attachedto opposite sides of the second post at a second location, wherein thesecond location is spaced apart longitudinally from the first location.13. The method of claim 10, wherein the four arms are positioned along afirst side of the sheet-like implant.
 14. The method of claim 13,wherein a second side of the sheet-like implant is placed in contactwith the tendon, the second side of the sheet-like implant beingopposite the first side of the sheet-like implant.
 15. The method ofclaim 1, wherein the sheath member includes a plurality of openingsopening into the lumen of the sheath member.
 16. The method of claim 15,further comprising: hydrating the sheet-like implant with a hydratingfluid passing through the openings into the lumen of the sheath memberwhile the sheet-like implant is disposed on the implant spreaderassembly in the folded configuration.
 17. The method of claim 16,wherein the step of hydrating the sheet-like implant includes submergingthe distal end of the sheath member into the hydrating fluid.
 18. Themethod of claim 1, further comprising a handle attached to the proximalend of the sheath member, wherein the implant delivery shaft extendsproximal of the handle.
 19. The method of claim 18, further comprising apushing member attached to the proximal end of the implant deliveryshaft.